(88 days)
Indications for use include:
- Elbow joint destruction which significantly compromises the activities of daily living ー
- Post-traumatic lesions or bone loss contributing to elbow instability -
- Ankylosed joints, especially in cases of bilateral ankylosis from causes other than active sepsis -
- Advanced rheumatoid, post-traumatic, or degenerative arthritis with incapacitating pain -
- Instability or loss of motion when the degree of joint or soft tissue damage precludes reliable osteosynthesis
- Acute comminuted articular fracture of the elbow joint surfaces that precludes less radical procedures, including 13-C3 fractures of the distal humerus
- Revision arthroplasty
Caution: This device is intended for cemented use only.
The Zimmer Nexel total Elbow is a total elbow prosthesis designed for use with bone cement. It is available in multiple sizes and in right and left configurations.
How the Device Functions: The Zimmer Nexel Total Elbow is an implant designed to replace the articulating surfaces of and restore motion to the humeroulnar (elbow) joint. The implant is a constrained device assembly and consists of the following components: humeral component, ulnar component, humeral bearing-A, ulnar bearings-B, axle pin and humeral screws.
The Following Scientific Concepts, Design Features and Physical Properties form the Basis for the Zimmer Nexel Total Elbow: The humeral component has a humeral stem designed to be implanted with bone cement into the patient's humeral medullary canal, an anterior flange designed to accept a bone graft and limit torsional and posterior migration, a humeral yoke with rounded corners to avoid the creation of stress risers within the medial and lateral humeral supracondylar columns, and plasma spray region to enhance fixation to bone cement within the medullary canal, and to improve fatigue strength. The ulnar component has an ulnar stem designed to be implanted with bone cement into the patient's ulnar medullary canal, an ulnar eye that is both highly polished and nitrogen-enriched to limit wear of the apposing polymer bearings, and plasma spray region to enhance fixation to bone cement within the medullary canal. Bearings A and B are designed to broadly distribute joint reaction forces.
Materials Used: The humeral and ulnar components are made of a titanium alloy, the bearings A and B are made of Vitamin E highly cross-linked polyethylene, and the humeral screws and axle pin are made of a cobalt-chromium-molybdenum alloy.
Here's an analysis of the acceptance criteria and study information for the Zimmer Nexel Total Elbow, based on the provided text:
Based on the provided K123862 510(k) summary, the device is a medical implant (total elbow prosthesis) and the study conducted is non-clinical performance testing for demonstrating substantial equivalence to a predicate device, rather than a clinical study involving human readers or AI. Therefore, many of the requested fields are not applicable in this context.
Here's the breakdown of the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Defined by Design Control activities demonstrating substantial equivalence to predicate device in terms of safety and efficacy | Meets performance requirements as defined by Design Control activities and is substantially equivalent to the predicate device in terms of safety and efficacy. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. This was non-clinical performance testing (e.g., fatigue, wear, durability), not a study on a test set of patient data.
- Data Provenance: Not applicable. The data came from laboratory testing of the device and its components, not from patient-derived data or specific countries.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. Ground truth for non-clinical performance testing typically refers to engineering specifications, industry standards, and established test methods, rather than expert human interpretation.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable, as there was no test set requiring human adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance
- MRMC Study: No. This was non-clinical testing of a physical implant, not an AI-assisted diagnostic tool.
- Effect Size: Not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: No. This is physical hardware, not an algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: Engineering specifications, industry standards, and established test methodologies for evaluating the mechanical properties, durability, and wear characteristics of the prosthetic components. This typically involves physical measurements against predefined limits.
8. The Sample Size for the Training Set
- Sample Size: Not applicable. This was non-clinical testing of a physical implant, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable, as there was no training set. The "ground truth" for the non-clinical testing was based on published standards, internal design specifications, and comparison to the predicate device's known performance.
§ 888.3150 Elbow joint metal/polymer constrained cemented prosthesis.
(a)
Identification. An elbow joint metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint. It is made of alloys, such as cobalt-chromium-molybdenum, or of these alloys and of an ultra-high molecular weight polyethylene bushing. The device prevents dislocation in more than one anatomic plane and consists of two components that are linked together. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,”
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra High Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,”
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(viii) ISO 14630:1997 “Non-active Surgical Implants—General Requirements,”
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 981-93 “Practice for Assessment of Compatibility of Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of Material on Muscle and Bone,”
(v) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(vi) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vii) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings, ” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”